A Master Protocol for Orforglipron in Participants With Obstructive Sleep Apnea and Obesity or Overweight (J5P-MC-GZRA)
Active, not recruiting
- Conditions
- OSA Overweight or Obesity
- Registration Number
- jRCT2031240499
- Lead Sponsor
- Eli Lilly Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 600
Inclusion Criteria
Master GZRA inclusion criteria
- have AHI >=15 on PSG as part of the trial at screening (V1).
- have body mass index (BMI) >=27 kg/m2 Study 1 GZ01 inclusion criteria
- Participants who are unable or unwilling to use PAP therapy.
- Participants must not have used PAP for at least 4 weeks prior to screening. Study 2 GZ02 inclusion criteria
- Participants who have been on PAP therapy for at least 3 consecutive months prior to study start and plan to continue PAP therapy during the study.
Exclusion Criteria
Master GZRA exclusion criteria
- Have Type 1 diabetes (T1D) or Type 2 diabetes (T2D), history of ketoacidosis, or hyperosmolar state/coma
- Have HbA1c >=6.5% (>= 48 mmol/mol), as determined by the central laboratory at Visit 1.
- Had any previous or planned upper airway surgery for sleep apnea or major ear, nose or throat surgery
- Have diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas >=50%, or diagnosis of Cheyne Stokes Respiration
- Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia.
- Active device treatment of OSA other than PAP therapy
- Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.
- Have a self-reported change in body weight >5 kg within 3 months prior to screening
- Have a prior or planned surgical treatment for obesity (excluding liposuction, abdominoplasty or cryolipolysis if performed more than 1 year prior to screening)
- Have a prior or planned endoscopic and/or present device-based therapy for obesity.
- Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity. Study 2 GZ02 exclusion criteria
- Have personal or job-related responsibilities, or in the opinion of the investigator have any situation that would make it unsafe to stop PAP therapy for 7 days prior to PSG testing during the study.
- Are unwilling to temporary discontinue PAP therapy for 7 days prior to PSG testing during the study.
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method - Change from Baseline in Apnea-Hypopnea Index (AHI) [ Time Frame: Baseline to Week 52
- Secondary Outcome Measures
Name Time Method